Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services

Overview

The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as a relapse prevention for opiate addicted inmates about to be released from prison. The experimental group is compared with a control group that commences methadone maintenance treatment before release. The hypothesises are that quality of life and criminal behaviour improve significantly in both groups compared to the month before incarceration. The experimental group is going to have significant less days with opioid use compared to the MMT group. We hypothesize furthermore that the implants can prevent death related to opiate overdose up to 6 months after commenced treatment.

Full Title of Study: “Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison – a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2008

Detailed Description

The probability of quick relapse to criminal activity and substance abuse after prison release is high among incarcerated opiate addicts. We attempt to prevent relapse to opiate abuse by two different means: Methadone Maintenance Treatment (MMT) versus Naltrexone implants, randomly allocated to two groups by sealed envelopes. All participants may choose in which group to continue after 6 (and again after 12) months, when the implants supposedly stop releasing naltrexone. The total treatment period is 18 months, continuation with MMT is optional after study termination.

Interventions

  • Drug: Naltrexone
    • surgically implanted naltrexone releasing during 5 to 6 months
  • Drug: Methadone
    • Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)

Arms, Groups and Cohorts

  • Experimental: Naltrexone implant
    • Naltrexone implant (GoMedical Inc. 6 months implant)
  • Active Comparator: Methadone
    • Methadone Maintenance Treatment

Clinical Trial Outcome Measures

Primary Measures

  • Drug use: self reported, urin / hair analysis
    • Time Frame: 6, 12 and 18 months
    • Use of heroin and other illicit drugs, self reported and in hair analyses

Secondary Measures

  • Distress / depression: BDI and Hopkins SCL-25
    • Time Frame: 6, 12 and 18 months
  • Quality of life, temporary satisfaction with life scale & self report as of ASI
    • Time Frame: 6, 12 and 18 months

Participating in This Clinical Trial

Inclusion Criteria

  • opiate addiction – living in greater Oslo area Exclusion Criteria:

  • psychosis / major depression, currently not treated – pregnancy – liver enzymes: ASAT or ALAT > threefold above upper boundary

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Oslo
  • Collaborator
    • The Research Council of Norway
  • Provider of Information About this Clinical Study
    • Philipp Lobmaier, University of Oslo
  • Overall Official(s)
    • Philipp Lobmaier, cand. med., Principal Investigator, Unit for Addiction Medicine
    • Helge Waal, professor, Study Director, Unit for Addiction Medicine, University of Oslo
    • Michael Abdelnoor, PhD, Study Chair, Ullevål University Hospital, Centre for clinical research
    • Jørg Mørland, professor, Study Chair, Division of Forensic Toxicology and Drug Abuse
    • Asbjørg S Christophersen, MD, Study Chair, Division of Forensic Toxicology and Drug Abuse

References

Hulse GK, Arnold-Reed DE, O'Neil G, Chan CT, Hansson RC. Achieving long-term continuous blood naltrexone and 6-beta-naltrexol coverage following sequential naltrexone implants. Addict Biol. 2004 Mar;9(1):67-72. doi: 10.1080/13556210410001674112.

Hulse GK, Arnold-Reed DE, O'Neil G, Chan CT, Hansson R, O'Neil P. Blood naltrexone and 6-beta-naltrexol levels following naltrexone implant: comparing two naltrexone implants. Addict Biol. 2004 Mar;9(1):59-65. doi: 10.1080/13556210410001674103.

Hulse GK, Tait RJ, Comer SD, Sullivan MA, Jacobs IG, Arnold-Reed D. Reducing hospital presentations for opioid overdose in patients treated with sustained release naltrexone implants. Drug Alcohol Depend. 2005 Sep 1;79(3):351-7. doi: 10.1016/j.drugalcdep.2005.02.009.

Olsen L, Christophersen AS, Frogopsahl G, Waal H, Morland J. Plasma concentrations during naltrexone implant treatment of opiate-dependent patients. Br J Clin Pharmacol. 2004 Aug;58(2):219-22. doi: 10.1111/j.1365-2125.2004.02122.x.

Bachs L, Waal H. [Naltrexone in the treatment of addiction]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1665-7. Norwegian.

Waal H, Christophersen AS, Frogopsahl G, Olsen LH, Morland J. [Naltrexone implants–a pilot project]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1660-1. Norwegian.

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